Howmedica Recalls Tritanium Posterior Lumbar Cage Implants Due to Fracture Risk
Howmedica Osteonics Corp. is recalling 28,461 Tritanium Posterior Lumbar cage implants because of reports of fractures occurring during or after surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (implant fracture) where injury has been reported, but the source does not explicitly state hospitalizations or deaths, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Howmedica Osteonics Corp. is recalling 28,461 units of the Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. These medical devices are intended for open, less invasive, and minimally invasive PLIF or TLIF surgical procedures. The recall covers all lots and specific model numbers listed in the agency's documentation, with a UDI of 07613327117943.
The recall is being issued because the surgical technique is being updated to caution against misuse. This update follows reports of cage fractures occurring both intra-operatively (during the surgery) and post-operatively (after the surgery). The distribution of the affected units was US Nationwide.
Patients who have had this implant placed should contact their surgeon or healthcare provider for guidance. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 28,461
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI: 07613327117943
- All lots
- Model Numbers 48950070
- 48950076
- 48950080
- 48950086
- 48950090
- 48950096
- 48950100
- 48950106
- 48950110
- 48950116
- 48950120
- 48950126
- 48950130
- 48950136
- 48950140
- 48950146
- 48951070
- 48951076
Distribution
Distributed nationwide across the United States.
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